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Maintenance with Selinexor/Placebo After Combination Chemotherapy in Participants with Endometrial Cancer [SIENDO]
Sponsor: Karyopharm Therapeutics Inc
Summary
This is a prospective, multicenter, double-blind, placebo-controlled, randomized Phase 3 study. The purpose of the study is to obtain evidence of efficacy for maintenance selinexor in participants with advanced or recurrent endometrial cancer. Participants with primary stage IV or recurrent disease who are in partial or complete response after having completed a single line of at least 12 weeks of taxane-platinum combo therapy will be randomized in a 2:1 manner to maintenance therapy with 80 milligram (mg) with selinexor once weekly (QW) or placebo until progression.
Official title: A Randomized, Double-Blind, Phase 3 Trial of Maintenance with Selinexor/ Placebo After Combination Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
263
Start Date
2018-01-05
Completion Date
2025-12
Last Updated
2025-01-20
Healthy Volunteers
No
Conditions
Interventions
Selinexor
Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Matching placebo for selinexor
Dose: 80 mg (4 tablets) or 60 mg (3 tablets); Dosage form: film-coated, immediate-release tablet of 20 mg each; Route of administration: oral
Locations (78)
Arizona Oncology
Tucson, Arizona, United States
Stanford University
Palo Alto, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Florida Cancer Specialists (Sarah Cannon Research Institute)
West Palm Beach, Florida, United States
Gynecological Cancer Institute of Chicago
Oak Lawn, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Indiana University Simon Cancer Center
Indianapolis, Indiana, United States
HCA Midwest Health - Kansas City (Sarah Cannon Research Institute)
Kansas City, Missouri, United States
NYU Langone
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Oklahoma Health Sciences Center - Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Oncology Associates of Oregon
Eugene, Oregon, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Tennessee Oncology Nashville (Sarah Cannon Research Institute)
Nashville, Tennessee, United States
Texas Oncology, Austin
Austin, Texas, United States
Texas Oncology DFW
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Texas Oncology DFW
Fort Worth, Texas, United States
VCU Massey Cancer Center
Richmond, Virginia, United States
UZ Gent
Ghent, Belgium
Jan Yperman Ziekenhuis
Ieper, Belgium
Universitaire Ziekenhuizen K.U. Leuven
Leuven, Belgium
CHU UCL Namur, Site Sainte-Elisabeth
Namur, Belgium
AZ Turnhout
Turnhout, Belgium
CHR Verviers
Verviers, Belgium
London Health Sciences Centre (London Regional Cancer Centre)
London, Ontario, Canada
University Health Network (PMCC)
Toronto, Ontario, Canada
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Maternal and Child Health Hospital
Nanchang, Jiangxi, China
Liaoning Cancer Hospital
Shenyang, Liaoning, China
Chongqing University Cancer Hospital
Chongqing, Shapingba District, China
Wenzhou Medical University - The First Affiliated Hospital
Wenzhou, Zhejiang, China
University Hospital Brno
Brno, Czechia
University Hospital Ostrava
Ostrava, Czechia
UH Královské Vinohrady
Prague, Czechia
General University Hospital in Prague
Prague, Czechia
Hospital Na Bulovce
Prague, Czechia
Charite Berlin Universitatsmedizin
Berlin, Germany
University Hospital Dresden
Dresden, Germany
DIAKOVERE KH gGmbH, Henriettenstift Hannover
Hanover, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, Germany
Universitätsfrauenklinik Mainz
Mainz, Germany
Klinikum der Universitat Munchen
Munich, Germany
Cartitas Klinikum Saarbrücken
Saarbrücken, Germany
Universitätsfrauenklinik Ulm
Ulm, Germany
Iaso Hospital
Marousi, Athens, Greece
ALEXANDRA Hospital
Athens, Greece, Greece
Euromedica General Clinic
Thessaloniki, Macedonia, Greece
Hillel Yaffe Medical Center
Hadera, Israel
Wolfson Medical Center
Holon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah Medical Center
Jerusalem, Israel
Sheba Medical Center
Ramat Gan, Israel
Istituto di Candiolo, FPO, IRCCS
Candiolo, Italy
Romagnolo Scientific Institute for the Study and Treatment of Tumors
Meldola, Italy
San Raffaele Hospital
Milan, Italy
Istituto Nazionale dei Tumori IRCCS - MILANO S.C. Ginecologia Oncologica
Milan, Italy
ULSS 3 SERENISSIMA UOC Oncologia Ed Ematologia Oncologica
Mirano, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" - NAPOLI Struttura Complessa Oncologia Medica Uro-Ginecologica
Naples, Italy
Agostino Gemelli University Polyclinic Foundation
Rome, Italy
Hospital Universitario Donostia
San Sebastián, Gipuzkoa, Spain
Hospital Universitari Vall d' Hebrón
Barcelona, Spain
Hospital Universitari Clínic de Barcelona
Barcelona, Spain
Consorci Sanitari de Terrassa
Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Madrid, Spain
Hospital Universitario Infanta Sofía
Madrid, Spain
Virgen de la Arrixaca University Clinical Hospital
Murcia, Spain
Hospital Son Llàtzer
Palma, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Instituto Valenciano de Oncología
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitario y Politécnico de La Fe
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain